S–Z

Sample suitability tests

Add the Sample suitability tests you require.

Important: The results of Sample suitability tests just affect the individual assay elements that are evaluated rather than the whole assay.


Data type	Multiplicity	Usage	Default value
T_SuitabilityTestsForDra	1...1	required	none

/Dose-response analysis/Analysis/Suitability tests/

/Test system for dose-response analysis/Suitability tests/

Scientifically acceptable

Marks dataset rows for positive or negative verification. Set to 'true' if you expect the assay of the row will be accepted. Set to 'false' if you expect the assay of the row will be rejected.


Data type	Multiplicity	Usage	Default value
T_ScientificallyAcceptable	1...1	required	none

/Equivalence margin development for dose-response analysis assays/Datatable/

Section

Specify which sections of referenced documents you require to develop or verify margins.


Data type	Multiplicity	Usage	Default value
T_EMDReferenceSectionFactor	1...1	required	none

/Equivalence margin development for dose-response analysis assays/Datatable/

Section key

Enter a Section key to restrict the data to the section identified by the key.

Note: The key only applies to document aggregation.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Setup/Observation data/Column: Well ID/

/Dose-response analysis/Setup/Observation data/Column: Response value/

Sequence step

Enter the sequence step of the assay element to be used for calculating the adjustment value.


Data type	Multiplicity	Usage	Default value
xs:nonNegativeInteger	0...1	optional	none

/Dose-response analysis/Analysis/Response data processing/choice/Adjustment/choice/by Assay element/

Sequence step

Enter the sequence step of the assay element to be used for calculating the normalization factor.


Data type	Multiplicity	Usage	Default value
xs:nonNegativeInteger	0...1	optional	none

/Dose-response analysis/Analysis/Response data processing/choice/Normalization/choice/by Assay element/

Settings

This section allows you to adjust various settings such as how graphs are displayed.


Data type	Multiplicity	Usage	Default value
T_Settings	0...1	optional	none

/Dose-response analysis/

Settings

This section allows you to enable and disable Development, Verification, and Visualization. You can also set Confidence and Tolerance levels. Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
T_EmdSettings	1...1	required	none

/Equivalence margin development for dose-response analysis assays/

Setup

This section allows you to set up this assay.

Expand the node to add or view information.

This section provides the following features:

Assay elements: Details all assay elements, that is, Standard sample, Test samples, and Control samples.
Preparation schemes: Defines Preparation schemes, which include the dilution sequences (in multi-dose schemes), Number of replicates per sequence step, and Predilution factors of assay elements.
Observation data: Sets up the data table displayed in the Observations editor. The table is created automatically based on the information you provide on assay elements and preparation schemes. But you can add or delete data columns such as the Well ID and Position factor columns.


Data type	Multiplicity	Usage	Default value
xs:empty	1...1	required	none

/Dose-response analysis/

Severity level of the test

Select the Severity level of the test. The severity level controls how failed tests affect results.*

The following options are available from the drop-down list:

Reject: If the test fails, no interpolated concentrations and additional calculation results are reported. For reporting the Overall test result, the test is considered 'Rejected'.
Warning: If the test fails, interpolated concentrations and additional calculation results are reported. For reporting the Overall test result, the test is considered 'Failed'.
Information: If the test fails, interpolated concentrations and additional calculation results are reported. For reporting the Overall test result, the test is considered 'Passed' (info available).

Note: Each dose-response analysis also provides a summary of test results, which is called 'Overall test result'.

The following table explains how the Severity levels of failed tests influence the Overall test result:


Overall test result	Failed tests of severity level 'Rejected'	Failed tests of severity level 'Warning'	Failed tests of severity level 'Information'
Passed	0	0	0
Passed (info available)	0	0	≥1
Failed	0	≥1	any number
Rejected	≥1	any number	any number

Note: If tests cannot be calculated and return 'not calculated' (NC) results (for example, if Fieller's formula is needed to calculate test results and computed values are outside the valid range), the Overall test result treats them like failed tests.

* When Assay suitability tests fail, they affect every sample in the assay. Sample suitability tests only affect the Overall test result of the individual sample.


Data type	Multiplicity	Usage	Default value
T_Severity	1...1	required	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test (parameter estimate)/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Parameter/property point estimate/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Mean squares (ANOVA)/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares (ANOVA)/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Value of interpolation/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Interval of interpolation/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Width of interpolation interval/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal number of outliers/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal sequence step CV(%)/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Coefficient of determination (R²)/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Response value range/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Test on effective concentration/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Response at effective concentration/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Transduction unit/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Recovery rate/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test (parameter estimate)/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Parameter/property point estimate/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Mean squares (ANOVA)/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares (ANOVA)/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Value of interpolation/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Interval of interpolation/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Width of interpolation interval/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal number of outliers/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal sequence step CV(%)/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Coefficient of determination (R²)/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Response value range/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Test on effective concentration/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Response at effective concentration/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Transduction unit/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Recovery rate/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Equivalence test (parameter estimate)/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Parameter/property point estimate/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Mean squares (ANOVA)/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares (ANOVA)/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Value of interpolation/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Interval of interpolation/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Width of interpolation interval/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal number of outliers/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal sequence step CV (%)/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Coefficient of determination (R²)/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Response value range/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Effective concentration/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Response at effective concentration/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Transduction unit/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Recovery rate/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Equivalence test (parameter estimate)/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Parameter/property point estimate/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Mean squares (ANOVA)/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares (ANOVA)/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Value of interpolation/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Interval of interpolation/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Width of interpolation interval/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal number of outliers/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal sequence step CV (%)/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Coefficient of determination (R²)/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Response value range/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Effective concentration/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Response at effective concentration/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Transduction unit/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Recovery rate/

Show error bars

Select the 'yes' option from the drop-down list to have error bars drawn at three standard deviations from the reported values. With this feature enabled, the graphs of multi-dose fits have error bars for every dilution sequence step with two or more observations.


Data type	Multiplicity	Usage	Default value
T_SSY_Boolean	1...1	required	none

/Dose-response analysis/Settings/Graphics/

Show observations

Select the 'yes' option from the drop-down list to visualize all observations on the graphs of assay elements with a multi-dose fit. With this feature enabled, a marker is drawn for each individual observation.


Data type	Multiplicity	Usage	Default value
T_SSY_Boolean	1...1	required	none

/Dose-response analysis/Settings/Graphics/

Simulation space

Define the standard errors and covariances for the simulation of model parameters. For each parameter, simulation samples a value from the uniform distribution within given limits.

If no Standard error is defined, the mean of the standard errors of the parameter in the referenced assays is used as default.
If no Covariances are defined, 0 is used as default.


Data type	Multiplicity	Usage	Default value
xs:empty	1...1	required	none

/Equivalence margin development for dose-response analysis assays/Visualization/

Single-dose scheme

This section allows you to define a Single-dose scheme. Single-dose schemes contain settings on Number of replicates and Predilution factors.

Expand the node to add or view information.

Note: In every assay element (sample), you must reference exactly one Preparation scheme. You can reference any Preparation scheme from more than one assay element.


Data type	Multiplicity	Usage	Default value
xs:empty	0...unbounded	optional	none

/Dose-response analysis/Setup/Preparation schemes/

Slope (linear models)

Use this test for the following models:

Linear parallel-line model
Slope ratio model


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Equivalence test (parameter estimate)/

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Test: Parameter/property point estimate/

/Equivalence margin development for dose-response analysis assays/Margin development/Equivalence test (parameter estimate)/

/Equivalence margin development for dose-response analysis assays/Margin development/Test: Parameter/property point estimate/

Solvent volume

This section allows you to specify the liquid volume in which the source material is to be dissolved.

Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
xs:empty	1...1	required	none

/Dose-response analysis/Setup/Assay elements/Standard/choice/Concentration: Defined by source material/

/Dose-response analysis/Setup/Assay elements/Test/choice/Concentration: Defined by source material/

/Dose-response analysis/Setup/Assay elements/Control/choice/Concentration: Defined by source material/

Source

Links this document to the source Equivalence margin development document.


Data type	Multiplicity	Usage	Default value
DocumentReference.EMD	0...1	optional	none

/Test system for dose-response analysis/

Square response transformation

Performs a square transformation of your response values.

Note: By default, the transformation you select is applied to every response value. Add a scope from the Creatable elements pane to restrict its application to an Assay element type or Assay element.

Tip: If you require 'No transformation', 'Logarithmic', or 'Square root response transformation', select the corresponding option from the 'Transformation' drop-down list.


Data type	Multiplicity	Usage	Default value
T_Empty	1...1	required	none

/Dose-response analysis/Analysis/Response data processing/choice/Transformation/choice/

Square root response transformation

Performs a square root transformation of your response values.

Note: By default, the transformation you select is applied to every response value. Add a scope from the Creatable elements pane to restrict its application to an Assay element type or Assay element.

Tip: If you require 'No transformation', 'Logarithmic', or 'Square response transformation', select the corresponding option from the 'Transformation' drop-down list.


Data type	Multiplicity	Usage	Default value
T_Empty	1...1	required	none

/Dose-response analysis/Analysis/Response data processing/choice/Transformation/choice/

Standard

This section allows you to provide information on the Standard, also referred to as standard sample or standard preparation.

Expand the node to add or view information.

Note: Calibration curve procedures require a Standard. Its regression curve is used to interpolate Test samples.

Tip: To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.


Data type	Multiplicity	Usage	Default value
T_AE_Standard	0...1	optional	none

/Dose-response analysis/Setup/Assay elements/

Standard deviation test

Provides a statistical outlier detection method based on multiples of the standard deviation.


Data type	Multiplicity	Usage	Default value
xs:empty	1...1	required	none

/Dose-response analysis/Analysis/Data selection schemes/Data selection scheme/choice/

Standard error: A upper asymptote (nonlinear models)

Enter a decimal number to specify the standard error of the upper asymptote. This parameter is used for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Simulation space/

Standard error: B parameter (nonlinear models)

Enter a decimal number to specify the standard error of the B parameter. This parameter is used for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Simulation space/

Standard error: C parameter (nonlinear models)

Enter a decimal number to specify the standard error of the C parameter. This parameter is used for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Simulation space/

Standard error: D lower asymptote (nonlinear models)

Enter a decimal number to specify the standard error of the lower asymptote. This parameter is used for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Simulation space/

Standard error: G asymmetry parameter (nonlinear models)

Enter a decimal number to specify the standard error of the asymmetry parameter. This parameter is used for the following models:

5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Simulation space/

Standard error: Intercept (linear models)

Enter a decimal number to specify the standard error of the intercept. This parameter is used for the following models:

Linear parallel-line model
Slope ratio model


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Simulation space/

Standard error: Slope (linear models)

Enter a decimal number to specify the standard error of the slope. This parameter is used for the following models:

Linear parallel-line model
Slope ratio model


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Simulation space/

Step start

Enter a step number to specify the first step of the partial range.


Data type	Multiplicity	Usage	Default value
xs:positiveInteger	1...1	required	none

/Dose-response analysis/Analysis/Data selection schemes/Data selection scheme/choice/Range partial/

Step stop

Enter a step number to specify the last step of the partial range.


Data type	Multiplicity	Usage	Default value
xs:positiveInteger	1...1	required	none

/Dose-response analysis/Analysis/Data selection schemes/Data selection scheme/choice/Range partial/

Stepwise concentration sequence

Allows you to define a sequence by specifying the Working concentration of each step individually.

To add a sequence step: Double-click Working concentration in the Creatable elements pane.

Note: The concentration you enter here for the first step of the sequence overrides the value implied by the predilution factors of this preparation scheme and the concentration settings of referencing assay elements. Please consult the help page on the Working concentration element for additional information.

Tip: Select a different sequence type from the drop-down list if you require.


Data type	Multiplicity	Usage	Default value
T_StepwiseConcentrationSequence	1...1	required	none

/Dose-response analysis/Setup/Preparation schemes/Multi-dose scheme/choice/

Stepwise dilution sequence

Allows you to define a sequence by specifying the Dilution factor of each step individually.

To add a sequence step: Double-click Dilution factor in the Creatable elements pane.

Note: If you add an Initial working concentration element to define the concentration of the first step in this sequence, the value you enter overrides the value implied by the predilution factors of this preparation scheme and the concentration settings of referencing assay elements. Please consult the help page on the Initial working concentration element for additional information.

Tip: Select a different sequence type from the drop-down list if you require.


Data type	Multiplicity	Usage	Default value
T_StepwiseDilutionSequence	1...1	required	none

/Dose-response analysis/Setup/Preparation schemes/Multi-dose scheme/choice/

Strategy

Defines a collection of tests and corresponding margins. Expand the node to add or view information.

Select developed margins or enter margins manually for each test. Please consult the help pages on particular tests for additional information.

Note: You can use development and verification data to evaluate test strategies.

Tip: Visualize test strategies. Please consult the Visualization section for additional information.


Data type	Multiplicity	Usage	Default value
T_TestStrategy	0...unbounded	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/

Subject

Enter the subject of this comment.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Comment/

/Test system for dose-response analysis/Comment/

Substance batch/lot number

Enter the substance batch or lot number, a combination of numbers, letters, and/or symbols. It identifies a batch (or lot), which allows you to infer the production and distribution history.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Documentation/

/Dose-response analysis/Setup/Assay elements/Standard/

/Dose-response analysis/Setup/Assay elements/Test/

/Dose-response analysis/Setup/Assay elements/Control/

Substance class

Enter the class of the substance such as the drug class.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Documentation/

/Dose-response analysis/Setup/Assay elements/Standard/

/Dose-response analysis/Setup/Assay elements/Test/

/Dose-response analysis/Setup/Assay elements/Control/

Substance description

Enter a description of the substance. Tip: You can enter multiline text.


Data type	Multiplicity	Usage	Default value
xs:string	0...1	optional	none

/Dose-response analysis/Documentation/

/Dose-response analysis/Setup/Assay elements/Standard/

/Dose-response analysis/Setup/Assay elements/Test/

/Dose-response analysis/Setup/Assay elements/Control/

Substance identification

Enter information to identify the substance.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Documentation/

/Dose-response analysis/Setup/Assay elements/Standard/

/Dose-response analysis/Setup/Assay elements/Test/

/Dose-response analysis/Setup/Assay elements/Control/

Substance name

Enter a name for the substance. Tip: You can enter a reference to a substance document instead. Select the Substance reference option from the drop-down list.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Documentation/choice/

/Dose-response analysis/Setup/Assay elements/Standard/choice/

/Dose-response analysis/Setup/Assay elements/Test/choice/

/Dose-response analysis/Setup/Assay elements/Control/choice/

Substance reference

Select a substance document. Tip: You can enter a substance name instead. Select the Substance name option from the drop-down list.


Data type	Multiplicity	Usage	Default value
DocumentReference.Substance	0...1	optional	none

/Dose-response analysis/Documentation/choice/

/Dose-response analysis/Setup/Assay elements/Standard/choice/

/Dose-response analysis/Setup/Assay elements/Test/choice/

/Dose-response analysis/Setup/Assay elements/Control/choice/

Substance sub-batch/sub-lot number

Enter the substance sub-batch or sub-lot number, a combination of numbers, letters, and/or symbols. It identifies a sub-batch (or sub-lot), which allows you to infer the production and distribution history.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Documentation/

/Dose-response analysis/Setup/Assay elements/Standard/

/Dose-response analysis/Setup/Assay elements/Test/

/Dose-response analysis/Setup/Assay elements/Control/

Substance variant

Enter the variant of the substance.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Dose-response analysis/Documentation/

/Dose-response analysis/Setup/Assay elements/Standard/

/Dose-response analysis/Setup/Assay elements/Test/

/Dose-response analysis/Setup/Assay elements/Control/

Suitability tests

This section allows you to define the statistical tests you require for your dose-response analysis.

The tests are organized into the following categories:

Assay suitability tests
Sample suitability tests

Expand the node to add or view information.

Note: Suitability tests are required to prove the validity of your assay runs.


Data type	Multiplicity	Usage	Default value
xs:empty	1...1	required	none

/Test system for dose-response analysis/

Suitability tests

This section allows you to define the statistical tests you require for your dose-response analysis.

The tests are organized into the following categories:

Assay suitability tests
Sample suitability tests

Expand the node to add or view information.

Note: Suitability tests are required to prove the validity of your assay runs.

Tip: Add a Test system reference if you have an external Test system document that defines the Suitability tests you need for this assay.


Data type	Multiplicity	Usage	Default value
xs:empty	1...1	required	none

/Dose-response analysis/Analysis/

Term

Currently, no information available.


Data type	Multiplicity	Usage	Default value
xs:string	1...unbounded	required	none

/Equivalence margin development for dose-response analysis assays/Datatable/Column: Assay element/Property filter/

Test: Coefficient of determination (R²)

Add one or several tests for the coefficient of determination (R²) to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Note: This test uses either R² or the adjusted R². Both are calculated for every individual assay element (sample) that has a multi-dose preparation scheme.

Select the R² value you want to test from the Type drop-down list.

The following options are available:

regular
adjusted

Note: To pass the test, the R² of the regression fit has to be greater than or equal to the Lower margin set in the test definition.

All


Data type	Multiplicity	Usage	Default value
T_CoefficientOfDeterminationRSquaredForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Effective concentration

Add one or several tests for the effective concentration to your assay.

The test definition allows you to set the EC percentile for which the interpolated response value is to be tested. The default is 50.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Note: To pass the test, the interpolated response value of the EC percentile has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
T_TestOnEcNForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Interval of interpolation

Add one or several tests for the interval of interpolation to your assay.

Note: This test is for assay elements that have a single-dose preparation scheme.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

The interval of interpolation is determined as follows: The system interpolates a value for each individual replicate. The 'interval of interpolation' is defined by the minimal and the maximal interpolation value for a single assay element (sample).

Note: To pass the test, the minimal interpolation value has to be greater than or equal to the Lower margin set in the test definition, and the maximal interpolation value has to be less than or equal to the Upper margin.

All

Test, Control


Data type	Multiplicity	Usage	Default value
T_InterpolationIntervalForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Maximal number of outliers

Add one or several tests for the maximal number of outliers to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Note: To pass the test, the number of outliers of the assay element (sample) has to be less than or equal to the Upper margin set in the test definition.

All

Test, Control


Data type	Multiplicity	Usage	Default value
T_MaximalNumberOfOutliersForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Maximal sequence step CV (%)

Add one or several tests for the maximal percentual coefficient of variation (CV) of sequence steps.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Note: To pass the test, all sequence step CVs of the assay element (sample) have to be less than or equal to the Upper margin set in the test definition.

The percentual CV is calculated as follows:

C V = | \frac{Standard Deviation}{Mean} | \cdot 100

All


Data type	Multiplicity	Usage	Default value
T_MaximalSequenceStepCVPercentForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Mean-squared lack of fit

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Mean-squared model

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Mean-squared pure error

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Mean-squared residual error

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Mean-squared total

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Mean squares (ANOVA)

Add one or several tests for mean squared-error values to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Select the ANOVA value you want to test from the Type drop-down list.

The following options are available:

Model
Residual error
Lack of fit
Pure error
Total

Note: The Type specifies which mean squared-error value of the ANOVA table is to be tested. To pass the test, this value must be less than or equal to the Upper margin set in this test definition.

Tip: Add the Lower margin element from the Creatable elements pane if you require.


Data type	Multiplicity	Usage	Default value
T_AnovaTestsForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Parameter/property point estimate


Data type	Multiplicity	Usage	Default value
L_PointEstimateTestsParameterEstimate	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Margin development/

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/

Test: Parameter/property point estimate

Add one or several tests for single parameters to your assay.

Note: These tests are for assay elements that have a multi-dose preparation scheme.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Important: Test definitions are ignored without notification if the Parameter you select results in invalid test definitions (for example, if a test cannot be performed for the model you use).

The following table lists all available tests and indicates which models they support:


Point estimate test on the:	Linear model	4-parameter logistic model	5-parameter logistic model	3-parameter logistic model with fixed lower or upper asymptote
Upper asymptote (A) (nonlinear models)	no	yes	yes	with fixed Lower asymptote
B parameter (nonlinear models)	no	yes	yes	yes
C parameter (nonlinear models)	no	yes	yes	yes
Lower asymptote (D) (nonlinear models)	no	yes	yes	with fixed Upper asymptote
Asymmetry parameter (G) (nonlinear models)	no	no	yes	no
Intercept (linear models)	yes	no	no	no
Slope (linear models)	yes	no	no	no
Slope (nonlinear models)	no	yes	yes	with fixed Upper asymptote
Difference of asymptotes (A – D) (nonlinear models)	no	yes	yes	no
Ratio of asymptotes (A / D) (nonlinear models)	no	yes	yes	no


Data type	Multiplicity	Usage	Default value
T_PropertyPointEstimateTestForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Recovery rate

Add one or several tests for the recovery rate to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

This test uses the recovery rate, which is defined as the quotient of the previously determined absolute concentration divided by the stated absolute concentration and is expressed as a percentage.

Note: To pass the test, the recovery rate has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
T_TestRecoveryRateForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Response at effective concentration

Add one or several tests for the response at effective concentration to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

This test uses the effective concentration, which results from the regression fit, to determine a response value for the Percentile you specify.

Transformed values are used if a Response transformation has been set. In this case, the regression fit is based on the transformed response. The calculation first determines the transformed response for the effective concentration and then reverses the transformation to receive an untransformed response value.

Note: To pass the test, the response at effective concentration has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
T_TestOnResponseAtECnForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Response value range

Add one or several tests for the response value range to your assay.

The test uses untransformed response values. Response adjustments and transformations are not applied.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Note: To pass the test, the minimal response value of the assay element has to be greater than or equal to the Lower margin set in the test definition, and the maximal response value of the assay element has to be less than or equal to the Upper margin.

All


Data type	Multiplicity	Usage	Default value
T_ResponseValueRangeForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test sample (unknown)

This section allows you to provide information on a Test sample, also referred to as preparation sample or unknown.

Expand the node to add or view information.

Note: Every Test sample has a Preparation scheme which can be of two types, that is, Multi-dose scheme or Single-dose scheme.

For Test samples that rely on Multi-dose schemes, a regression is performed during calculation.
For Test samples that rely on Single-dose schemes, a dose value is interpolated using the regression curve of the Standard sample.

Tip: To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.

Tip: The Report group element allows you to combine assay elements (samples) for calculating an average, performing regression analyses, displaying them in overlay plots, and printing them next to each other in reports.


Data type	Multiplicity	Usage	Default value
T_AE_Test	0...unbounded	optional	none

/Dose-response analysis/Setup/Assay elements/

Test strategies

This section allows you to define the test strategies you want to evaluate in verification and visualization. Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
T_TestStrategies	1...1	required	none

/Equivalence margin development for dose-response analysis assays/

Test strategy verification

Select the 'yes' option from the drop-down list to use the development and verification assays to evaluate all test strategies you define.


Data type	Multiplicity	Usage	Default value
T_BinaryType	1...1	required	none

/Equivalence margin development for dose-response analysis assays/Settings/

Test strategy visualization

Select the 'yes' option from the drop-down list to generate and visualize the parameter configurations that pass the defined test strategies. The parameter configurations are processed for each test strategy separately.

Note: Additional tests are not considered in the visualization.


Data type	Multiplicity	Usage	Default value
T_BinaryType	1...1	required	none

/Equivalence margin development for dose-response analysis assays/Settings/

Test: Sum of squares (ANOVA)

Add one or several tests for sum-of-squares values to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Select the ANOVA value you want to test from the Type drop-down list.

The following options are available:

Model
Residual error
Lack of fit
Pure error
Total

Note: The Type specifies which sum-of-squares value of the ANOVA table is to be tested. To pass the test, this value must be less than or equal to the Upper margin set in this test definition.

Tip: Add the Lower margin element from the Creatable elements pane if you require.


Data type	Multiplicity	Usage	Default value
T_AnovaTestsForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Sum-of-squares lack of fit

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Sum-of-squares model

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Sum-of-squares pure error

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Sum-of-squares residual error

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test: Sum-of-squares total

Use this test for the following models:

Linear parallel-line model
4-parameter logistic fit
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
T_SingleTestStrategy	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Test strategies/Strategy/Anova terms/

/Equivalence margin development for dose-response analysis assays/Margin development/Anova terms/

Test system for dose-response analysis

Defines a collection of Suitability tests and corresponding margins for Dose-response analysis.

Note: You can reference this Test system definition document from Dose-response analysis documents. When you calculate an assay that references this document, the test(s) specified in this document are applied to the assay.

Navigate through the properties to select or enter settings you require for this Test system for dose-response analysis:

1. Expand the node to add or view information.

The second level of the document structure displays the Name and Date of the document.

2. Double-click the Identification element in the Creatable elements pane to add it to the document.

Note: To delete an element from the document, right-click the element in the document structure and select the Delete element option from the pop-up menu.

3. Double-click the Comment element in the Creatable elements pane to add a Comment section to the document.


Data type	Multiplicity	Usage	Default value
xs:empty	1...1	required	none

Top level

Test system reference

Select the Test system document that defines the Suitability tests you need for this assay.


Data type	Multiplicity	Usage	Default value
DocumentReference.TestSystemDefinition.Dra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/

Test: Transduction unit

Add one or several tests for the transduction unit to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Transduction unit = Total number of cells * EC50 * Response at EC50 / Maximal response

Note: To pass the test, the transduction unit has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

You can set the following parameters:

Total number of cells: Sets the Total number of cells to be used in the calculation of the transduction unit.
Maximal response: Sets the Maximal response to be used in the calculation of the transduction unit.
Unit: Defines the Unit to be printed for the transduction unit in reports.

Tip: To define a maximal response, add the Maximal response element from the Creatable elements pane. If you do not enter a value for Maximal response, the calculation uses the upper asymptote of the regression of the standard (for the linear model).


Data type	Multiplicity	Usage	Default value
T_TestOnTransductionUnitForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Value of interpolation

Add one or several tests for the value of interpolation to your assay.

Note: This test is for assay elements that have a single-dose preparation scheme.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

The value of interpolation is determined as follows: The system interpolates a value for each individual replicate. The 'value of interpolation' is the mean of all valid interpolation values for a single assay element (sample). The test uses the delogarithmized value.

Note: To pass the test, the value of interpolation has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

All

Test, Control


Data type	Multiplicity	Usage	Default value
T_ValueOfInterpolationForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Test: Width of interpolation interval

Add one or several tests for the width of the interpolation interval to your assay.

Note: This test is for assay elements that have a single-dose preparation scheme.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

The width of interpolation interval is determined as follows: The system interpolates a value for each individual replicate. The 'width of interpolation interval' is the difference of the maximal minus the minimal interpolation value for a single assay element (sample).

Note: To pass the test, the width of the interpolation interval has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Select the value you want to test from the drop-down list(s).

The following options are available:

Width absolute for Working concentration: Uses the difference of maximal minus minimal Working concentration.
Width absolute for Absolute concentration: Uses the difference of maximal minus minimal Absolute concentration. The 'Absolute concentration' is the Source material concentration if available or the Stock solution concentration.
Width relative: Uses the difference of maximal minus minimal concentration divided by the mean of the interpolation values.

All

Test, Control


Data type	Multiplicity	Usage	Default value
T_WidthInterpolationIntervalForDra	0...unbounded	optional	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/

Text

Enter your comment.

Tip: You can enter multiline text. You can also add additional Text elements.


Data type	Multiplicity	Usage	Default value
xs:string	0...unbounded	optional	none

/Dose-response analysis/Comment/

/Test system for dose-response analysis/Comment/

Tolerance level

Specifies what proportion of data is to lie within developed margins. Select 95%, for example, to exclude the outer 5% data values from the calculation. A common value is 95%.

Note: A higher Tolerance level results in a greater equivalence range (distance between equivalence margins).

Note: Use of Tolerance levels below 100% in margin development inevitably causes some development assays to fail tests based on calculated margins. Select the 100% tolerance level if you do not want acceptable development assays to fail.


Data type	Multiplicity	Usage	Default value
T_ToleranceLevel	1...1	required	none

/Equivalence margin development for dose-response analysis assays/Settings/

Total number of cells

Enter the Total number of cells to be used to calculate the transduction unit.


Data type	Multiplicity	Usage	Default value
T_PositiveDouble	1...1	required	none

/Dose-response analysis/Analysis/Additional calculations/Transduction unit/

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Transduction unit/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Transduction unit/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Transduction unit/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Transduction unit/

Transduction unit

Allows you to calculate and report the Transduction unit.

Expand the node to add or view information.

Note: This calculation and the values you enter here are independent of the values in the Transduction unit test.

Tip: Add a Maximal response element from the Creatable elements pane.

Transduction unit = Total number of cells * EC50 * Response at EC50 / Maximal response


Data type	Multiplicity	Usage	Default value
xs:empty	0...1	optional	none

/Dose-response analysis/Analysis/Additional calculations/

Transformation

Transform your response values using Logarithmic, Square, or Square root response transformation.

Expand the node to add or view information.

Example: Use this feature to mitigate problems caused by the heteroscedasticity of your response data.

Tip: Add a scope element from the Creatable elements pane if you require.


Data type	Multiplicity	Usage	Default value
xs:empty	0...1	optional	none

/Dose-response analysis/Analysis/Response data processing/choice/

Transformed dose maximum

Enter a decimal number to be used as greatest value of the x-axis in simulation plots.


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Transformed dose range/

Transformed dose minimum

Enter a decimal number to be used as least value of the x-axis in simulation plots.


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/Transformed dose range/

Transformed dose range

Defines the least and greatest value of the x-axis used for simulation plots.

Note: These values only apply if no assays are referenced. Otherwise, the values of the referenced assays are used.

Note: If the Model selected for visualization is 'Slope ratio', the values are considered absolute dose values. For all other models, the values are considered log dose values.


Data type	Multiplicity	Usage	Default value
xs:empty	0...1	optional	none

/Equivalence margin development for dose-response analysis assays/Visualization/

Type (absolute width of interpolation interval)

Select the concentration to be used from the drop-down list.

The following options are available:

Working concentration: Tests for the difference of maximum minus minimum Working concentration.
Absolute concentration: Tests for the difference of maximum minus minimum Absolute concentration. The 'Absolute concentration' is the Source material concentration if available or the Stock solution concentration.


Data type	Multiplicity	Usage	Default value
T_WidthAbsolute	1...1	required	none

/Dose-response analysis/Analysis/Suitability tests/Assay suitability tests/choice/Test: Width of interpolation interval/choice/Width absolute/

/Dose-response analysis/Analysis/Suitability tests/Sample suitability tests/choice/Test: Width of interpolation interval/choice/Width absolute/

/Test system for dose-response analysis/Suitability tests/Assay suitability tests/choice/Test: Width of interpolation interval/choice/Width absolute/

/Test system for dose-response analysis/Suitability tests/Sample suitability tests/choice/Test: Width of interpolation interval/choice/Width absolute/

Type (ANOVA)

Select the ANOVA value you want to test from the drop-down list.


Data type	Multiplicity	Usage	Default value
T_AnovaTypes	1...1	required	none